SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable, precision radiopharmaceuticals for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ABD-147, the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC).

加利福尼亚州南旧金山（商业新闻短讯）——Abdera Therapeutics Inc.是一家生物制药公司，利用其先进的抗体工程ROVEr™平台设计和开发用于癌症的可调精密放射性药物，今天宣布，美国食品和药物管理局（FDA）已批准该公司针对ABD-147的研究性新药（IND）申请，ABD-147是第一个靶向放射性药物的δ样配体3（DLL3），用于治疗小细胞肺癌（SCLC）和大细胞神经内分泌癌（LCNEC）。

Abdera plans to initiate a Phase 1 clinical trial in the second half of 2024..

Abdera计划在2024年下半年启动一期临床试验。。

ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing DLL3. DLL3 is a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues..

ABD-147是一种新一代精密放射性药物生物疗法，旨在向表达DLL3的实体瘤递送锕225（225Ac），一种高效的α发射放射性同位素。DLL3是一种在神经内分泌肿瘤表面发现的蛋白质，但很少在正常细胞或组织表面表达。。

“ABD-147 represents a potential best-in-class treatment for SCLC and other aggressive neuroendocrine tumors,” said Philippe Bishop, M.D., chief medical officer. “Leveraging our ROVEr platform, we custom-engineered ABD-147 with optimized pharmacokinetic properties and tumor penetration to destroy tumor cells while limiting radiation toxicity to the body.

首席医疗官Philippe Bishop医学博士说：“ABD-147代表了SCLC和其他侵袭性神经内分泌肿瘤的潜在最佳治疗方法。”。“利用我们的漫游者平台，我们定制了具有优化药代动力学特性和肿瘤穿透性的ABD-147，以破坏肿瘤细胞，同时限制对身体的辐射毒性。

We are hopeful this highly potent next generation radiotherapeutic will provide a potential breakthrough addressing a critical medical need for the treatment of SCLC and other high-grade neuroendocrine cancers. We look forward to initiating a Phase 1 clinical trial of ABD-147 later this year.”.

我们希望这种高效的下一代放射治疗剂将为解决SCLC和其他高级神经内分泌癌治疗的关键医疗需求提供潜在的突破。我们期待着在今年晚些时候启动ABD-147的1期临床试验。”。

The Phase 1, first-in-human, open-label clinical study aims to evaluate the safety and preliminary efficacy of 225Ac-ABD-147 in patients with SCLC or LCNEC who previously received platinum-based therapy. The study will determine the recommended dose regimen for future development.

第一阶段，首次人体开放标签临床研究旨在评估225Ac-ABD-147在先前接受铂类治疗的SCLC或LCNEC患者中的安全性和初步疗效。该研究将确定未来发展的推荐剂量方案。

“FDA clearance of our first IND marks a major milestone for Abdera as we transition into a clinical-stage radiopharmaceutical company,” said Lori Lyons-Williams, president and chief executive officer. “We believe our ROVEr™ platform uniquely enables a new wave of innovation in targeted radiotherapeutics, with ABD-147 representing the first in a robust pipeline of custom-engineered programs we are advancing to the clinic.”.

总裁兼首席执行官洛里·莱昂斯·威廉姆斯（LoriLyons Williams）表示：“FDA批准我们的第一个IND标志着Abdera向临床阶段放射性制药公司过渡的一个重要里程碑。

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

关于小细胞肺癌和大细胞神经内分泌癌

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers.

据报道，SCLC和LCNEC的全球发病率约为325000名患者，预计到2029年每年将增加4%。据报道，在美国，每年约有35000例新病例。所有肺癌病例中有15%是高度神经内分泌癌。

These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC.

这些癌症在任何类型的肺部肿瘤中都具有最具侵袭性的临床过程，并且经常转移到身体的其他部位，包括大脑，肝脏和骨骼。据报道，未经治疗，诊断的中位生存期仅为2至4个月。经过治疗，SCLC的五年总生存率为5%至10%，LCNEC为15%至25%。

SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed..

SCLC和LCNEC通常预后不良，迫切需要新的治疗选择。。

About ABD-147

关于ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs.

ABD-147是一种靶向放射性药物生物疗法，旨在以高亲和力向表达δ样配体3（DLL3）的实体瘤递送锕225（225Ac）（一种高效的α发射放射性同位素）。DLL3是Notch途径中的一种蛋白质，对于肺中神经内分泌与上皮细胞分化的发展和调节至关重要。

In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy..

在包括小细胞肺癌（SCLC）在内的某些高级神经内分泌癌中，DLL3在80%以上的病例中被上调并在细胞表面特异性表达。相反，DLL3不存在或很少在非恶性细胞表面表达。鉴于DLL3表达对癌细胞的高度特异性和独特的作用机制，DLL3代表了通过靶向放疗治疗SCLC和其他DLL3+实体瘤的引人注目的靶标。。

About the ROVEr™ Platform

关于ROVEr™平台

Abdera’s Radio Optimized Vector Engineering (ROVEr™) platform enables the company to custom-engineer targeted radiopharmaceuticals with tunable pharmacokinetic (PK) properties to achieve high tumor uptake while minimizing renal exposure and mitigating other systemic radiotoxicities such as myelosuppression.

Abdera的无线电优化载体工程（ROVEr™）平台使该公司能够定制具有可调药代动力学（PK）特性的靶向放射性药物，以实现高肿瘤摄取，同时最大程度地减少肾脏暴露并减轻其他全身性放射毒性，如骨髓抑制。

Abdera can optimize the delivery and therapeutic index of potent radioisotopes capable of emitting powerful alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments..

Abdera可以优化有效放射性同位素的输送和治疗指数，这些放射性同位素能够发射强大的α或β颗粒，选择性地破坏肿瘤细胞，同时保留健康细胞，为患者提供潜在的变革性新癌症治疗。。

Abdera’s approach offers the ability to design radiotherapeutics against virtually any cancer target expressed on the cell surface. Coupled with a highly potent mechanism of cell killing, the ROVEr platform is uniquely poised to exploit both high- and low-expressing targets to selectively deliver therapeutic levels of radioisotope to cancer cells..

Abdera的方法提供了针对细胞表面表达的几乎任何癌症靶标设计放射治疗剂的能力。

About Abdera

关于Abdera

Abdera Therapeutics is a biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Abdera’s Radio Optimized Vector Engineering (ROVEr™) platform enables the company to engineer potential best-in-class therapies for both clinically validated and novel targets that deliver potent radioisotopes capable of emitting alpha or beta particles to selectively destroy cancer cells.

Abdera Therapeutics是一家生物制药公司，利用抗体工程设计和开发用于癌症的新型精密放射性药物。Abdera的无线电优化载体工程（ROVEr™）平台使该公司能够为临床验证和新型靶标设计潜在的同类最佳疗法，这些靶标提供能够发射α或β粒子以选择性破坏癌细胞的有效放射性同位素。

Abdera’s lead program, ABD-147, is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Headquartered in South San Francisco, CA, Abdera also has offices in Vancouver, British Columbia, Canada.

Abdera的领先项目ABD-147是一种下一代精确放射性药物生物疗法，旨在将锕225（225Ac）递送至表达δ样配体3（DLL3）的实体瘤，用于治疗小细胞肺癌（SCLC）和大细胞神经内分泌癌（LCNEC）。Abdera总部位于加利福尼亚州南旧金山，在加拿大不列颠哥伦比亚省温哥华也设有办事处。